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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217526
Company: NAVINTA LLC

Products on ANDA 217526

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM PHENYLACETATE AND SODIUM BENZOATE	SODIUM BENZOATE; SODIUM PHENYLACETATE	10%;10% (2GM/20ML; 2GM/20ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217526

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/14/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217526

SODIUM PHENYLACETATE AND SODIUM BENZOATE

SOLUTION;INTRAVENOUS; 10%;10% (2GM/20ML; 2GM/20ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM PHENYLACETATE AND SODIUM BENZOATE	SODIUM BENZOATE; SODIUM PHENYLACETATE	10%;10% (2GM/20ML; 2GM/20ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217526	NAVINTA LLC

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